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FDA 510(k)

HIGH PRESSURE SETS-400 PSI

K-Number: K100576 · 2010-12-17

ApplicantIcu Medical, Inc.
Decision Date2010-12-17
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HIGH PRESSURE SETS-400 PSI is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2010-12-17 under 510(k) number K100576. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGH PRESSURE SETS-400 PSI?

HIGH PRESSURE SETS-400 PSI is a medical device that received FDA 510(k) clearance on 2010-12-17. The listed applicant is Icu Medical, Inc.. The 510(k) number is K100576.

When did HIGH PRESSURE SETS-400 PSI receive FDA 510(k) clearance?

HIGH PRESSURE SETS-400 PSI received FDA 510(k) clearance on 2010-12-17, under 510(k) number K100576.

Who is the listed applicant for HIGH PRESSURE SETS-400 PSI?

The FDA 510(k) record lists Icu Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIGH PRESSURE SETS-400 PSI?

The FDA product code for HIGH PRESSURE SETS-400 PSI is FPA.

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Related Devices (Code: FPA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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